FDA Office of Oncology Drug Products Director Richard Pazdur plans to convene an advisory committee meeting to clarify standards for use of progression-free survival data, a move prompted by industry's aggressive adoption of the surrogate endpoint and, more broadly, the gradual decline in the level of drug benefit that sponsors seek to use in support of a cancer drug approval
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As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.
Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”
The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.
